- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03814460
Stroke and Assessment of Muscle Tone
Stroke and Myotonometer: Validity, Reliability and Discrimination Between the Mechanical and Sensory Component of Spasticity
Spasticity is defined as a state of increased muscle tone, which evokes an increased resistance to a passive and fast stretching of the muscle. Indeed, the degree of spasticity depends, among other things, on the stretching velocity performed to the muscle. However, most of the tools used in the clinical setting to assess spasticity do not take into account the relationship between increased muscle tone and speed of stretching. Instead of that, muscle tone is usually assessed in a relaxed position of the muscle.
Likewise, to date, despite the functional disabilities related to the presence of chronic pain after a stroke, no previous study has correlated muscle tone and pressure pain sensitivity within this population
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Sevilla, Spain, 41009
- University of Sevilla
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Seville, Spain, 41009
- Physiotherapy Department, University of Seville
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Be older than 18 years
- Clinical diagnosis of stroke, confirmed using a MRI.
- No previous history of other strokes.
- Increases muscle tone in upper and lower extremities (punctuation equal to or superior to 1 in the Tardieu Scale, Ashworth Scale)
- Ability to understand the study goals, follow simple instructions and provide informed consent.
- Score equal to or superior to 24 in the Minimental State Examination.
Exclusion Criteria:
- Any other confirmed neurological disorder that may influence muscle tone (multiple sclerosis, Parkinson, muscle dystrophies...)
- A chronic musculoskeletal disorder in the upper or lower limb.
- Previous history of surgery in the upper or lower extremities.
- Changes in the medication intake that may affect muscle tone assessments in the 48 hours before data collection.
- Having received botulin toxin in gastrocnemius or biceps brachii muscles in the 30 days before data collection.
- A concomitant acute infection during data collection.
- A previous epileptic crisis in the week before the study or during the study.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
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Control Group
A control group of healthy subjects with no previous history of neurological disorders or conditions.
This group pf participants will be selected in a similar population based-cohort than the other two study groups.
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Evaluation of Muscle state of tension, self-reported response to mechanical pressure pain and muscle thickness.
The evaluation process of muscle tone and pressure pain sensitivity will be carried out following a topographical mapping covering myotendinous and muscle belly sites in the biceps brachii and the gastrocnemius muscles
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Acute Stroke Group
In this group, participants who suffered a previous stroke within 3 months before data collection will be included.
|
Evaluation of Muscle state of tension, self-reported response to mechanical pressure pain and muscle thickness.
The evaluation process of muscle tone and pressure pain sensitivity will be carried out following a topographical mapping covering myotendinous and muscle belly sites in the biceps brachii and the gastrocnemius muscles
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Chronic Stroke Group
In this group, only participants who have suffered a previous stroke of more than 3 months duration before data collection will be included.
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Evaluation of Muscle state of tension, self-reported response to mechanical pressure pain and muscle thickness.
The evaluation process of muscle tone and pressure pain sensitivity will be carried out following a topographical mapping covering myotendinous and muscle belly sites in the biceps brachii and the gastrocnemius muscles
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pressure Pain Threshold, assessed by Manual Pressure Algometry
Time Frame: One time assessment
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A handheld electronic pressure algometer with a 1-cm2 contact probe will be used.
Pressure pain thresholds (PPTs), as the minimum necessary pressure force to evoke pain, will be assessed bilaterally over biceps brachii and the gastrocnemius muscles (medial and lateral).
Assessments will be made using a topographical mapping covering myotendinous and muscle belly sites in the above mentioned muscles.
A 30-second break will be used between assessments to prevent bruising, and an average of the two measures over each site will be calculated for the statistical analysis.
Pressure algometry is reliable in healthy individuals, and in stroke patients
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One time assessment
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Muscle Tone Assessment, using the modified Tardieu Scale
Time Frame: One time assessment
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The modified Tardieu Scale is the most common tool used in the clinical setting to evaluate the muscle tone.
The muscle response to a slow and fast stretching will be performed.
During the fast stretching, the joint angle in which the muscle responds with difficulty will be collected using an electrogoniometer.
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One time assessment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle Stiffness, assessed by a myotonometer
Time Frame: One time assessment
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The stiffness of the biceps brachii and gastrocnemius muscles will be collected using a handheld myotonometer device, the so-called MyotonPRO, (Myoton AS, Estonia). The MyotonPRO is small, non-invasive, and it has shown good validity and high reliability in larger and smaller body muscles. This device delivers a multi-scan mode of three brief mechanical impulses, each one shortly followed by a quick release, to record the damped natural oscillation of the muscle using an accelerometer. Evaluations will be made in the affected and non-affected sides of stroke patients and in dominant and non-dominant sides of control participants. |
One time assessment
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Muscle State of Tension (Muscle Tone), assessed by a myotonometer
Time Frame: One time assessment
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The tone of the biceps brachii and gastrocnemius muscles will be collected using a handheld myotonometer device, the MyotonPRO, (Myoton AS, Estonia). The MyotonPRO is small, non-invasive, and it has shown good validity and high reliability in larger and smaller body muscles. This device delivers a multi-scan mode of three brief mechanical impulses, each one shortly followed by a quick release, to record the damped natural oscillation of the muscle using an accelerometer. Evaluations will be made in the affected and non-affected sides of stroke patients and in dominant and non-dominant sides of control participants. |
One time assessment
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Muscle Thickness
Time Frame: One time assessment
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The thickness of the assessed muscles will be evaluated using ecography. Muscle thickness will be assessed in one point corresponding to a myotendinous site and one point corresponding to a muscle belly location in both, the biceps brachii and gastrocnemius muscles. Evaluations will be made in the affected and non-affected sides of stroke patients and in dominant and non-dominant sides of control participants. |
One time assessment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Isabel Garcia Bernal, PT, Physiotherapy Department, University of Sevilla, Spain
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Myoton18
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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